The DEBATE Study "DEvelopment of Endotype-based Biomarkers for the Monitoring of Greek pATiEnts With CRSwNP" (DEBATE)
2026年7月21日 更新者：AstraZeneca
Given the high variability in the inflammatory profiles of CRSwNP (Chronic rhinosinusitis with nasal polyps) patients that influence both disease phenotype and response to treatment, exploring further potential targets is crucial for advancing novel biologic treatment strategies.
By indicating the efficacy of targeted therapy, as well as determining clinical features, endotyping of CRSwNP may offer a useful tool to better tailor treatment approaches in this heterogenous patient population.
This study is the first national effort to collect data on inflammatory markers and burden of CRSwNP patients in Greece aiming at identifying disease endotypes based on patients' inflammatory profile.
調査の概要
詳細な説明
A participant may withdraw from the study at any time at the participant's own request for any reason (or without providing any reason) without any implication on participant's rights.
Patients who discontinue should be asked about the reason(s) for their discontinuation.
If the participant withdraws consent for disclosure of future information, AstraZeneca may retain and continue to use any data collected before such a withdrawal of consent
研究の種類
観察的
入学 (推定)
230
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：AstraZeneca Clinical Study Information Center
- 電話番号：1-877-240-9479
- メール：information.center@astrazeneca.com
研究場所
-
-
-
Alexandroupoli、ギリシャ
- 募集
- Research Site
-
Athens、ギリシャ
- まだ募集していません
- Research Site
-
Heraklion、ギリシャ
- まだ募集していません
- Research Site
-
Thessaloniki、ギリシャ
- まだ募集していません
- Research Site
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
サンプリング方法
非確率サンプル
調査対象母集団
CRSwNP patients who are scheduled to undergo first ESS (prospective patients) will be recruited from approximately 6 Ear-Nose-Throat (ENT) and 1 pulmonology clinics.
Moreover, CRSwNP and CRSsNP patients who have already performed their first ESS in the period between 2012 and enrolment and have stored nasal tissue samples (retrospective patients) will be recruited from 1 ENT clinic.
説明
Inclusion Criteria:
- Age ≥ 18 years
- If CRSwNP group:
Physician-diagnosed severe, uncontrolled CRSwNP according to the EUFOREA/EPOS 2020 and ICAR-RS 2021 guidelines with:
- CRSwNP severity consistent with the need for surgery as defined by a total nasal polyp score (NPS) of ≥5 (≥2 for each nostril)
- Nasal Congestion Score (NCS) of ≥2
- Ongoing documented symptoms of CRSwNP for > 8 weeks before surgery
If CRSsNP group:
Diagnosis of CRSsNP according to the EUFOREA/EPOS 2020 and ICAR-RS 2021 guidelines
- Have performed in the period between 2012 and enrolment or are scheduled to perform endoscopic sinus surgery (ESS) for the first time at enrolment
- Have available nasal polyp tissue sample from the first endoscopic sinus surgery (ESS)
- Have provided signed and dated written informed consent
- If CRSwNP group:
Patients receiving any standard of care treatment for CRSwNP, provided the participant is stable on that treatment for ≥30 days
Exclusion Criteria:
- Patients with cystic fibrosis or immunodeficiency
- Presence of acute exacerbation of CRS symptoms within 2 weeks prior to surgery
- Use of systemic corticosteroids within 30 days prior to surgery, or antileukotrienes within 15 days prior to surgery, or biologic therapy prior to surgery
- Not adequate amount (<0.15g) or quality (e.g. storage temperature, contamination) of tissue sample for analyses
- Not available blood (serum) sample, only for patients scheduled to perform endoscopic sinus surgery (ESS) for the first time at the date of enrolment, for analyses.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
Prospective (CRSwNP)
CRSwNP patients who are scheduled to undergo first ESS (Endoscopic sinus surgery)
|
Not applicable - NIS study
|
|
Retrospective (CRSwNP)
CRSwNP patients who have already performed their first ESS in the period between 2012 and enrolment and have stored nasal tissue samples
|
Not applicable - NIS study
|
|
Retrospective (CRSsNP)
CRSsNP (Chronic rhinosinusitis without nasal polyps) patients who have already performed their first ESS in the period between 2012 and enrolment and have stored nasal tissue samples
|
Not applicable - NIS study
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Characterization of nasal tissue-secreted cytokines/chemokines in patients with CRSwNP
時間枠：At Visit 1 (day 1)
|
Cytokine/chemokine analysis of the fresh extracted nasal tissue following first ESS will be performed by Luminex and ELISA analysis
|
At Visit 1 (day 1)
|
|
Characterization of nasal tissue immune cell populations in prospective patients with CRSwNP
時間枠：At Visit 1 (day 1)
|
Immunophenotypic analysis by spectral flow cytometry of all main immune cell types, as well as detailed characterization of all T cell subsets will be performed in the fresh samples.
|
At Visit 1 (day 1)
|
|
Characterization of eosinophil and neutrophil cell counts in patients with CRSwNP
時間枠：At Visit 1 (day 1)
|
Eosinophil and neutrophil cell counts will be recorded, as per the EPOS 2020, eosinophilia is defined as >10 eosinophils/hpf.
|
At Visit 1 (day 1)
|
|
Characterization of nasal histological alterations in retrospective patients with CRSwNP
時間枠：At Visit 1 (day 1)
|
Tissue morphology and potential tissue destruction and nasal epithelium remodeling by standard histology staining (e.g.
hematoxylin and eosin, Periodic Acid-Schiff (PAS), and Sirius Red staining) will be assessed in stored nasal polyp tissue paraffin sections or paraffin blocks.
|
At Visit 1 (day 1)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
1i. Description of demographics of CRSwNP patients before and during 24 months after first endoscopic sinus surgery (ESS)
時間枠：Up to 24 ± 2 months (through study completion)
|
Demographics at study entry/screening (age, sex, ethnicity, smoking status, cigarettes/day/year, alcohol status (units/week), body measurements (BMI kg/m2), employment status, educational level, residence area) will be recorded
|
Up to 24 ± 2 months (through study completion)
|
|
1i. Description of medical history of CRSwNP patients before and during 24 months after first endoscopic sinus surgery (ESS)
時間枠：Up to 24 ± 2 months (through study completion)
|
Patients' medical history, including the date of first and severe CRSwNP diagnosis, comorbidities, and disease management [use (yes/no) of saline, systemic/local glucocorticoids, biologics, antibiotics], will be reported at the time of enrolment and during 24 months after first ESS.
|
Up to 24 ± 2 months (through study completion)
|
|
1i. Description of first ESS characteristics in CRSwNP patients
時間枠：At Visit 1 (day 1)
|
Time to first ESS from CRSwNP diagnosis and from severe CRSwNP diagnosis will be assessed
|
At Visit 1 (day 1)
|
|
1ii. Assessment of 22-item Sinonasal Outcome Test (SNOT-22) score in CRSwNP patients
時間枠：Up to 24 ± 2 months (through study completion)
|
The 22-item Sinonasal Outcome Test (SNOT-22), which is a health-related quality of life (HRQoL) evaluation with each item scored on a Likert scale ranging from 0 "No problem" to 5 "Problem as bad as it can be".
|
Up to 24 ± 2 months (through study completion)
|
|
1ii. Assessment of The Nasal Polyposis Symptom Diary (NPSD) in CRSwNP patients
時間枠：Up to 24 ± 2 months (through study completion)
|
The Nasal Polyposis Symptom Diary (NPSD), which is a short patient-reported outcome (PRO) tool comprising 11 items (8 symptom-specific, 2 symptom-impact, and 1 optional medication-compliance).
The Total Symptom Score (TSS) is a summary of the first 8 symptom-specific items, scored on a 4-point scale [0-none, 1-mild, 2-moderate, 3-severe], with a resulting score from 0 to 24
|
Up to 24 ± 2 months (through study completion)
|
|
1ii. Assessment of the Asthma Control Test (ACT) in CRSwNP patients (if comorbidity with asthma)
時間枠：Up to 24 ± 2 months (through study completion)
|
The Asthma Control Test (ACT), a patient-based tool for identifying patients with poorly controlled asthma that includes 5 items assessing the frequency of shortness of breath and general asthma symptoms, use of rescue medications, the effect of asthma on daily functioning, and overall self-assessment of asthma control.
The ACT responses for each of the items are summed to yield a score ranging from 5 (poor control of asthma) to 25 (complete control of asthma), with higher scores reflecting greater asthma control.
|
Up to 24 ± 2 months (through study completion)
|
|
1iii. Assessment of Nasal Polyps Score (NPS) score in CRSwNP patients
時間枠：Up to 6 months before Visit 1 (day 1) & at Visit 2 (24 ± 2 months)
|
NPS is a physician-reported tool that grades the extent/severity of nasal polyps based on evaluation by nasal endoscopy.
Each nostril is scored on a scale of 0 - "No nasal polyps" to 4 - "Large nasal polyps causing complete obstruction of the inferior nasal cavity", with the total score being the sum of left and right nostril scores (range: 0-8).
|
Up to 6 months before Visit 1 (day 1) & at Visit 2 (24 ± 2 months)
|
|
1iii. Assessment of imaging results in CRSwNP patients
時間枠：Up to 6 months before Visit 1 (day 1) & at Visit 2 (24 ± 2 months)
|
The Lund-Mackay (LM) CT score that evaluates sinus opacification on CT scans.
This score ranges from 0 -"complete lucency of all sinuses" to 24 - "complete opacity of all sinuses"
|
Up to 6 months before Visit 1 (day 1) & at Visit 2 (24 ± 2 months)
|
|
2. Characterization of blood cytokines/chemokines in prospective patients with CRSwNP
時間枠：At Visit 1 (day 1)
|
Cytokine/chemokine analysis of blood samples following first ESS will be performed by Luminex and ELISA analysis
|
At Visit 1 (day 1)
|
|
2. Characterization of blood immune cell populations in prospective patients with CRSwNP
時間枠：At Visit 1 (day 1)
|
Immunophenotypic analysis by spectral flow cytometry of all main immune cell types, as well as detailed characterization of all T cell subsets will be performed in the fresh samples.
|
At Visit 1 (day 1)
|
|
2. Characterization of serum immunoglobulin levels in prospective patients with CRSwNP
時間枠：At Visit 1 (day 1)
|
Serum immunoglobulin levels [total IgE, specific IgE to staphylococcal enterotoxins (SE-IgE)]
|
At Visit 1 (day 1)
|
|
2. Characterization of WBC count in prospective patients with CRSwNP
時間枠：At Visit 1 (day 1)
|
Differential WBC count (incl.
absolute count) will be recorded
|
At Visit 1 (day 1)
|
|
2. Characterization of RBC count in prospective patients with CRSwNP
時間枠：At Visit 1 (day 1)
|
RBC count will be recorded
|
At Visit 1 (day 1)
|
|
3. Association of time to CRSwNP recurrence and CRSwNP endotypes over 24 months following first ESS in CRSwNP patients
時間枠：Up to 24 ± 2 months (through study completion)
|
The number of CRSwNP recurrences along with the date(s) of recurrence(s) will be recorded in the eCRF by the investigator at 24 months following first ESS for CRSwNP patients (including retrospective CRSwNP patients, if data are available).
The time to relapse during the 24-month follow-up will be also estimated.
|
Up to 24 ± 2 months (through study completion)
|
|
4. Differences in cytokine/chemokine levels between retrospective patients with CRSwNP and CRSsNP
時間枠：At Visit 1 (day 1)
|
Endotypes of CRSsNP patients who have performed first ESS in the period between 2012 and enrolment (retrospective patients) will be determined based on cytokine/chemokine analysis of frozen extracted nasal tissue from ESS, including Fractalkine, GM-CSF, IFNγ, IL-1β, IL-2, IL-4, IL-5, IL-6, IL-7, IL-8, IL-10, IL-12, (p70), IL-13, IL-17A, IL-21, IL-23, ITAC, MIP-1α, MIP-1β, MIP-3α, TNF-α, TSLP, IL-9, IL-33, IL-17E/IL-25, TGFb1, IL-22
|
At Visit 1 (day 1)
|
|
4. Differences in eosinophil and neutrophil cell counts between retrospective patients with CRSwNP and CRSsNP
時間枠：At Visit 1 (day 1)
|
Eosinophil and neutrophil cell counts will be recorded.
As per the EPOS 2020, eosinophilia is defined as >10 eosinophils/hpf
|
At Visit 1 (day 1)
|
|
4. Differences in nasal tissue alterations between retrospective patients with CRSwNP and CRSsNP
時間枠：At Visit 1 (day 1)
|
tissue morphology and potential nasal tissue destruction and remodeling by standard histology staining (e.g.
Hematoxylin and eosin, Periodic acid-Schiff (PAS), and Sirius Red staining) will be assessed in stored nasal polyp tissue paraffin sections or paraffin blocks.
Depending on the nature of tissue pathology, further immunohistochemical analysis will be performed with the use of specific antibodies, such as markers for epithelial barrier integrity (e.g.
E-cadherin or Cytokeratin), tissue remodeling (e.g.
MMP-9) or chronic damage monitored by fibrosis (e.g.
α-SMA or collagen)
|
At Visit 1 (day 1)
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
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研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2026年6月29日
一次修了 (推定)
2029年12月31日
研究の完了 (推定)
2029年12月31日
試験登録日
最初に提出
2026年5月18日
QC基準を満たした最初の提出物
2026年6月17日
最初の投稿 (実際)
2026年6月23日
学習記録の更新
投稿された最後の更新 (実際)
2026年7月22日
QC基準を満たした最後の更新が送信されました
2026年7月21日
最終確認日
2026年4月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- D5242R00007
個々の参加者データ (IPD) の計画
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はい
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All request will be evaluated as per the AZ disclosure commitment:
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For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
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